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Antibiotic resistance is a growing public health concern; antibiotics used in animals raised for human consumption contributes to this problem. Three federal agencies address this issue--the Department of Health and Human Services' (HHS) Food and Drug Administration (FDA) and Centers for Disease Control and Prevention (CDC), and the Department of Agriculture (USDA). GAO examined (1) scientific evidence on the transference of antibiotic resistance from animals to humans and extent of potential harm to human health, (2) agencies' efforts to assess and address these risks, (3) the types of data needed to support research on these risks and extent to which the agencies collect these data, (4) use of antibiotics in animals in the United States compared with its key agricultural trading partners and competitors, and (5) information on how use has affected trade.

Scientific evidence has shown that certain bacteria that are resistant to antibiotics are transferred from animals to humans through the consumption or handling of meat that contains antibiotic-resistant bacteria. However, researchers disagree about the extent of harm to human health from this transference. Many studies have found that the use of antibiotics in animals poses significant risks for human health, but a small number of studies contend that the health risks of the transference are minimal. Federal agencies have expanded their efforts to assess the extent of antibiotic resistance, but the effectiveness of their efforts to reduce human health risk is not yet known. FDA, CDC, and USDA have increased their surveillance activities related to antibiotic resistance. In addition, FDA has taken administrative action to prohibit the use of a fluroquinolone in poultry. FDA has identified animal drugs that are critically important for human health and begun reviewing currently approved drugs using a risk assessment framework that it recently issued for determining the human health risks of animal antibiotics. However, because FDA's initial reviews of approved animal drugs using this framework have focused on other drugs and have taken at least 2 years, FDA's reviews of critically important drugs may not be completed for some time. Although federal agencies have made some progress in monitoring antibiotic resistance, they lack important data on antibiotic use in animals to support research on human health risks. These data, such as the type and quantity of antibiotics and purpose for their use by species, are needed to determine the linkages between antibiotic use in animals and emerging resistant bacteria. In addition, these data can help assess human health risks from this use and develop and evaluate strategies for mitigating resistance. The United States and several of its key agricultural trading partners and competitors differ in their use of antibiotics in animals in two important areas: the specific antibiotics allowed for growth promotion and availability of antibiotics to producers (by prescription or over the counter). For example, the United States and Canada allow some antibiotics important in human medicine to be used for growth promotion, but the European Union (EU) and New Zealand do not. Regarding over the counter sales of antibiotics, the United States is generally less restrictive than the EU. Antibiotic use in animals has not yet been a significant factor affecting U.S. international trade in meat and poultry, although the presence of antibiotic residues in meat has had some impact, according to government and industry officials. Instead, countries raise other food safety issues, such as hormone use and animal diseases. However, according to these officials, antibiotic use in animals may emerge as a factor in the future. They particularly noted that the EU could object to U.S. use of antibiotics for growth promotion as its member countries are phasing out that use.

Recommendations for Executive Action

Status: Closed - Not Implemented

Comments: FDA responded by email that it was devoting considerable resources to its work on antimicrobial resistance. FDA's work includes tracking resistance patterns through the National Antimicrobial Resistance Monitoring System and participating in the Public Health Action Plan and international Codex activities. FDA has expanded its analysis of previously approved applications for the use of penicillin in animal feeds to include a review of relevant published literature, new information submitted by sponsors of one of the involved products, and the information contained in two Citizen Petitions submitted to FDA in March of 1999 and April of 2005. When FDA completes an analysis of all of the relevant information, FDA will be able to make the necessary determinations related to the pending Citizen's petitions and the previously approved applications." However, FDA did not respond when asked which risk assessments were completed, what determinations were made, what actions were taken, and how many FTE's and other resources were devoted to this. FDA has not implemented this recommendation.

Recommendation: Because of the emerging public health problems associated with antibiotic resistance in humans and the scientific evidence indicating that antibioticresistant bacteria are passed from animals to humans, the Commissioner of FDA should expedite FDA's risk assessments of the antibiotics used in animals that the agency has identified as critically important to human health to determine if action is necessary to restrict or prohibit animal uses in order to safeguard human health.

Comments: HHS has not provided GAO with information that addresses what the department has done in response to this recommendation.

Recommendation: Because more data on antibiotic use in animals--such as the total quantity used, by class; the species in which they are used; the purpose of the use, such as disease treatment or growth promotion; and the method used to administer--are needed to further address the risk of antibiotic resistance, the Secretaries of Agriculture and of Health and Human Services should jointly develop and implement a plan for collecting data on antibiotic use in animals that will adequately (1) support research on the relationship between this use and emerging antibiotic-resistant bacteria, (2) help assess the human health risk related to antibiotic use in animals, and (3) help the agencies develop strategies to mitigate antibiotic resistance.

Agency Affected: Department of Health and Human Services

Status: Closed - Not Implemented

Comments: USDA has continued collecting data on antibiotic use in animals and emergence of resistant disease strains in the USDA/ARS Antimicrobial Resistance Research Unit in Athens, Georgia. This work has progressed steadily but slowly, because of the limited resources, according to the unit's Research Leader. The research has focused on swine and data from two studies under the National Animal Health Monitoring System (NAHMS)that took random samples of swine in 17 states. While USDA has continued its efforts independently, it has not worked jointly with HHS to develop and implement a focused plan, which was the purpose of the recommendation.

Recommendation: Because more data on antibiotic use in animals--such as the total quantity used, by class; the species in which they are used; the purpose of the use, such as disease treatment or growth promotion; and the method used to administer--are needed to further address the risk of antibiotic resistance, the Secretaries of Agriculture and of Health and Human Services should jointly develop and implement a plan for collecting data on antibiotic use in animals that will adequately (1) support research on the relationship between this use and emerging antibiotic-resistant bacteria, (2) help assess the human health risk related to antibiotic use in animals, and (3) help the agencies develop strategies to mitigate antibiotic resistance.